Late last year, the U.S. Food and Drug Administration (FDA) announced that it would not finalize the guidance on agency oversight of laboratory developed tests (LDTs) that it proposed back in 2014—at least not yet. Instead, the FDA said it would work with the new administration and Congress "to get our approach right." See "FDA Oversight of LDTs Delayed for Consultation with New Administration, Stakeholders," DTET, Nov. 2016, p. 1. With that in mind, on Jan. 13, 2017, the FDA issued a discussion paper summarizing the public feedback it has received on the 2014 draft guidance and outlining the key features of a possible alternative approach to FDA regulation of LDTs. Later that same month, health care organizations emphasized the urgency of addressing LDT safety with a letter urging Congress to act sooner rather than later in addressing oversight. Here is an overview of these latest developments concerning LDTs. FDA Discussion Paper Analyzes Stakeholder Feedback As part of the feedback process, the FDA asked stakeholders to suggest how they think the agency should regulate LDTs. The agency summarized the feedback it received in its January discussion paper, noting that the various proposals shared some similar features, including: Risk-based approach; Premarket […]